OriCAR-017: GPCRC5D-directed chimeric antigen receptor modified T cells
Study summary
An open label, dose exploratory clinical study to evaluate the safety, efficacy, and pharmacokinetics of OriCAR-017 in R/RMM
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Main Inclusion Criteria:
* Diagnosis of R/RMM according to the IMWG criteria;
* Expected survival period is \>12 weeks;
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 or 2 at the time of ICF signature;
* The expression of GPRC5D in bone marrow plasma cells membrane is more than 20% by flow cytometry and/or immunohistochemistry, multiple myeloma with measurable lesions, and at least one of the following criteria must be met:
1. Serum M protein \>5 g/L;
2. Urine M protein level \>200 mg/24 hour;
3. Serum free light chain (sFLC) \>100 mg/L and K/λ FLC ratio is abnormal;
4. Primitive immature or monoclonal plasma cells \>5% by bone marrow cytology or flow cytometry.
* Subjects who had received at least 3 prior lines of therapy including (but not limited to) immunomodulatory drugs (IMiDs), proteasome inhibitors, anti-CD38 monoclonal antibodies, etc., but have failed treatment, including those who have experienced relapse (within 12 months), refractory or intolerant to the last line treatment regimen.
Main Exclusion Criteria:
* Smoldering myeloma (asymptomatic)
* Multiple myeloma with only extramedullary lesions;
* Plasma cell leukemia;
* Concurrent amyloidosis;
* Central nervous system metastasis, leptomeningeal disease or metastatic central compression;
* HBsAg or HbcAb is positive, and the quantitative detection of hepatitis B virus (HBV) DNA in peripheral blood is more than 100 copies/L; hepatitis C virus (HCV) antibody and HCV RNA in peripheral blood is positive; human immunodeficiency virus (HIV) antibody positive; syphilis antibody is positive at Screening; Cytomegalovirus DNA test is positive;
* Had hypersensitivity or intolerance to any drug/excipient (including conditioning chemotherapy) used in this study;
* Previously received treatment targeting GPRC5D, including but not limited to antibodies, ADC, or CAR-T;
* Subjects who received autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks of Screening Visit or who plan to undergo ASCT during the study;
* Any uncontrolled active infection within 4 weeks prior to ICF signing or leukapheresis requires parenteral antibiotic, antiviral, or antifungal treatment
* Major surgery within 28 days prior to Screening Visit with the exception of a biopsy and an insertion of a central venous catheter or during the study;
* Subjects who received allogeneic stem cell therapy;
* Subjects complications or other conditions evaluated by investigators may affect compliance with the protocol or make them unsuitable to participate in this study;
* Pregnant or breastfeeding.
Primary outcome measure(s)
Maximum tolerated dose of OriCAR-017-P1 — Up to 28 days The MTD is defined as the highest dose with an observed incidence of DLT in no more than one out of six patients treated at a particular dose level.
Dose-limiting toxicity (DLT) — Up to 28 days tolerability
Trial sites (5)
Facility
City
Region
Status
The First Affiliated Hospital College of Medicine Zhejiang University
Hangzhou
Zhejiang
Recruiting
Beijing GoBroad Hospital
Beijing
China
Not Yet Recruiting
The First Affiliated Hospital with Nanjing Medical University
Nanjing
China
Not Yet Recruiting
Tongji Hospital of Tongji University
Shanghai
China
Not Yet Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan
China
Recruiting
More OriCell Therapeutics Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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